In our quick comparison, we compare COVID-19 antigen test products available on the market that are approved for self-sampling in the EU, based on the manufacturer’s instructions for use based on official clinical studies and other publicly available background information (Paul Ehrlich Institute comparative analysis).
AmonMed
We have always been cautious about saliva tests, as there are many technical and operational uncertainties about them, despite their apparent simplicity. But our main problem was that they were lagging behind international research in terms of sensitivity, and there were no clinical trials with a consistent methodology, broken down by brand, to make them comparable with nasal and other saliva tests. That’s why we didn’t market saliva tests. Caution is still advised for 99% of saliva tests, as they are usually of questionable quality even on the basis of the instructions for use, but their analytical properties are at a minimum unverifiable. Their specificity can be good, but when there is an epidemic wave, it is the sensitivity that is important, and they usually fall short (see the article by Tamás Kollár, biologist). However, some tests have appeared, but only a few, that show sensitivity comparable to the best nasal tests. In a study comparing 122 antigen tests by the Paul Ehrlich Institute, two saliva tests were among the top performers, one of which is likely to be available for retail sale after 18 November (the other top-performing test is the UltiMed test, licensed for institutional use). We understand that this test will be mid-range in price, so it represents excellent value for money. At high virus concentrations it has 100% sensitivity, but even at medium virus concentrations it is around 90%, which is very rare, only a few tests reach this level.
Biosynex
A major European player. As the first antibody manufacturer to build a brand in our country, it gained a huge awareness (and sales) advantage, although in many cases its antibody product was purchased when an antigen test was needed to test for a new infection. However, the test is of high quality, as confirmed by independent clinical trials. This is the most expensive antigen product, and the price is only slowly moving downwards. The high price is no longer justified by any real quality or market advantage. It is a medium product in terms of price/value, but not contraindicated. Distributed by Izinta and DiagPro.
www.izinta.hu
,
www.diagpro.hu
Boson
Its manufacturer is a very important player in the Chinese market. Boson’s product was the first antigen product to be launched by A-Lab Pharma (Arvali Ltd.) with a large-scale advertising campaign, so it is probably the most sought-after tool now. So much so, that suddenly dozens of distributors have appeared on the market, some with links to manufacturers, some taking advantage of the free flow of products in the EU, sourcing from who knows where, transporting and storing the product. Boson is similar in quality to Biosynex, but usually 1000-2000 HUF cheaper in price. It is worth buying the factory products distributed by the largest wholesalers (Bellis, Hungaropharma, Phoenix Pharma), not the grey imports for which the manufacturer does not take responsibility. Good value for money, recommended.
www.bosonteszt.hu
,
www.alabpharma.hu
Wesail
Less well-known, but listed manufacturer. The COVID-19 antigen product appears to be low-end in quality and price according to the factory brochure. Its sensitivity is 82.4%. If price is important, you should go for it, although on the web you can find products with better official analytical values for a little more money (e.g. Boson) or even for a little less (the new EasyDiagnosis/eDiagnosis, see later). In the medical devices genre, the highest possible safety can be achieved by purchasing tests with the highest possible analytical sensitivity. Failure to do so during the COVID period can have serious consequences, so consider the importance of analytical values before purchasing any product. Distributed by Legal Beauty Ltd. www.virusmaszk.hu
Contact details
It is a renowned manufacturer, but has so far failed to achieve unquestionable quality for its COVID products, in some countries
serious objections
accompanied the antibody test pathway (India), although in such cases there is often measurement uncertainty on the part of the device testers. Based on its analytical values, it should be one of the better quality products for antigen testing, but independent clinical studies have shown that its actual values are well below the values in the instructions, with only 88% in the range 20-25 Ct (high virus concentration), where Biosynex, Boson and Easy Diagnosis are 100%, and Wondfo 0% in the range 25-30 Ct (typical tests are between 40-80%, the best are above 80%). A value of 0 is quite uncommon among antigen tests, if it is real, then many positive cases may not be detected, i.e. the instructions may be somewhat misleading. Product not recommended by WHO July 2021 figures. It is also interesting that the original English box does not say nasal-garat, but nasal-root test (nasal), while the Hungarian box says nasal-garat, which is a sampling used only for professional tests (incorrect translation).
Beright and Screenitalia saliva tests
The former is sold at a low price, the latter at a high price, but the same product is manufactured by Alltest, a major player in China, which produces hundreds of different quick tests for several brands and under its own brand. Their analytical values place these tests in the lower category (90.1% accuracy). Although the saliva test genre is in principle attractive to many people because of the supposed simplicity and painlessness of the sampling, these saliva tests do not yet reach the quality level that can be confidently recommended, according to the data in the instructions for use. The sample size in the 400+ clinical study is, at this point, weakening faith in the product, as the medium sensitivity seems to be quite certain. Beright’s distributor is Legal Beauty Ltd, Screenitalia’s is the Isinta-DiagPro duo. In terms of value for money, Beright is in a similar category to Wesail, while Screenitalia seems a less good choice due to its high price.
www.diagpro.hu
,
www.izinta.hu
and
www.virusmaszk.hu
Easy Diagnosis or eDiagnosis
It is a very important, listed manufacturer with a huge capacity. It has an outstanding specificity of 100% and a high sensitivity of 100% at 20-25 Ct (high virus concentration) and even exceeds the Boson value between 25-30 Ct (moderately high virus concentration). Its sampling rod is perhaps the most user-friendly for self-sampling, being shorter and harder than many manufacturers’ instruments, making it easier to use. It only needs to be rotated 1.5-2 cm inside the nasal cavity, the smallest of similar nasal cavity tests, meaning it is no longer painful to use, with little itching. Distributor A-Lab Pharma is keeping its prices very low due to the expected high volume. This device is now available to all security-conscious customers, and is a clear value for money. At the point of sale, where pharmacies pass on their low price advantage to the consumer, it seems a good choice from both a price and analytical value perspective. It is now available in more and more pharmacies, and if you can’t find it yet, you can get it here:
www.alabpharma.hu
,
www.gyorstesztlabor.hu
ROCHE
Following the success of Roche’s nasopharyngeal and nasal products, a residential device has been launched in a family pack (5pcs per pack). The product is manufactured by SD Biosensor, a renowned Korean manufacturer that has also launched its products independently under its own brand. The ROCHE rapid tests, which are also used in the healthcare sector, have received positive feedback, so a similar product for the general public is expected to be of better quality than the data in the user manual would suggest. Further research would be needed to form a firm opinion on a relatively fresh product. Distributed by ROCHE Hungary and four key partners. www.roche.hu
2021. November post updated 1 September 2022.